Regulatory Focus™ > News Articles > Regulatory Recon: Novartis CEO Predicts US Drug Pricing Overhaul; Chinese Scientists to Launch First

Regulatory Recon: Novartis CEO Predicts US Drug Pricing Overhaul Chinese Scientists to Launch First Human CRISPR Trial (21 July 2016)

Posted 21 July 2016 | By Zachary Brennan 

Regulatory Recon: Novartis CEO Predicts US Drug Pricing Overhaul Chinese Scientists to Launch First Human CRISPR Trial (21 July 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

In Focus: US                                      

  • FDA's Breakthrough Workload Will Be Eased By Hiring Reviewers With PDUFA VI Funds (Pink Sheet-$)
  • Crestor Generics To Launch After 12-Day Delay (Pink Sheet-$) (NY Times-$)
  • Novartis CEO predicts drug pricing overhaul in U.S. after the election, whoever wins (Fierce)
  • At the Republican convention, drug maker lobbies for more coverage of obesity drugs (STAT)
  • Biogen CEO George Scangos to step down (Fierce)
  • Legislation is no 'cure' for what ails medical device safety (Philadelphia Inquirer)
  • FDA Seeks New Data for Merck’s BLA for Bezlotoxumab (Press)
  • Amgen, Allergan clear Phase III with Herceptin biosimilar (Fierce) (Reuters)

In Focus: International

  • Chinese scientists to pioneer first human CRISPR trial (Nature News) (STAT)
  • India’s Drug Approvals Near Record Despite FDA Inspection Blitz (Bloomberg)
  • Science advice for Europe (Science)
  • NICE publishes final guidance recommending ataluren for children with Duchenne muscular dystrophy (NICE)
  • Competence, Training and Conduct Requirements for Regulatory Reviewers (IMDRF)
  • Updated Conflict of interest policy (UK’s MHRA)
  • UK’s MHRA Annual Report and Accounts 2015 to 2016 (MHRA)
  • African HIV/tuberculosis institutes merge (Science)
  • Sales of mid- and high-priced drugs in Russia continue to decline (PharmaLetter-$)
  • ABPI hits back at Corbyn criticism of pharma (PharmaLetter-$)

US: Pharmaceuticals and Biotechnology

  • Big Pharma’s cash flows in a flurry of partnerships (Boston Globe)
  • Pairing New Cancer Drugs With Older Ones Bolsters Roche Profit (Bloomberg)
  • Sidelined at the FDA, AstraZeneca watches as new team seizes rival drug in $1.5B Relypsa buyout (Endpoints) (Press)
  • Gilead: As Earnings Loom, Don't Expect A Guidance Cut (Forbes)
  • Merck KGaA building $115 million life science facility in MA (BioPharma Dive)

US: Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Puma Biotechnology Submits New Drug Application for PB272 (Neratinib) to U.S. FDA for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer (Press)
  • Gilead’s Odefsey (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) Meets Primary 48-Week Objective in Two Phase 3b Studies (Press)
  • Dr. Reddy's Countersuit Rejected In Purple Pill Trademark Row (Law360-$)
  • Genetic-risk assessment of GWAS-derived susceptibility loci for type 2 diabetes in a 10 year follow-up of a population-based cohort study (Journal of Human Genetics)

Medical Devices

  • US FDA Urges National Device Evaluation System Incorporating UDI (Emergo)
  • FDA/Patient Workshop - Partnering with Patients on CDRH’s Research Agenda for Assistive and/or Neurostimulation Devices, August 1, 2016 (FDA)
  • Regulatory decisions & notices (medical devices & IVDs) (Australia’s TGA)
  • Medtronic Neuromodulation Deep Brain Stimulation system pocket adaptors (Australia’s TGA)
  • Alere INRatio PT/INR monitor system (Australia’s TGA)
  • Stryker translates CMS claims data for hospitals (Mass Device)
  • Philips connects Trilogy ventilators to the Internet of Things (Mass Device)

US: Assorted and Government

  • Public Health, Human Rights and Faith Organizations Question State Department Pressure Against Global Access to Medicines Initiatives (Public Citizen)

Upcoming Meetings and Events             


  • New CEO Szela cuts Aegerion staff again, pulls Juxtapid out of the EU (Endpoints)
  • Committee for Medicinal Products for Veterinary Use (EMA)
  • EMA Accepts Another Biosimilar Application (India Times)
  • German startup raises $34M for first-in-class complement inhibitor (Fierce)



  • Costs of Zika among the many unknowns of the virus (Modern Healthcare)
  • Countering the Zika epidemic in Latin America (Science)

General Health and Other Interesting Articles

  • Do genomic conflicts drive evolution? (Science)
  • Loss of independence post-surgery linked to poor outcomes (Reuters)
  • To Avoid Malaria, Try Sleeping With A Chicken At Your Bedside (NPR)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

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